This study is being done to see if a drug called long acting methylphenidate (Concerta) is safe and effective as a treatment for problems with mental function in adults infected with HIV.

A subset of patients with HIV-associated memory loss have a defect in the speed with which they learn and process information. Methylphenidate drugs, such as Ritalin or Concerta, have been shown on tests to improve the ability to rapidly absorb information; these tests are called "reaction time tests". These drugs are already FDA-approved to treat Attention Deficit Disorders: ADD or ADHD.

At baseline, all subjects get tests of memory and brain function; then they are split into two groups. One group on this study will receive Concerta for 2 weeks, and a second group will receive a placebo x 2 weeks. After that period both groups will receive memory and other tests of brain function, and then the groups will switch. The first group will receive placebo and the second will receive Concerta x 2 weeks, followed by more memory and neurological tests. After that all subjects will have the option to receive Concerta for free for 8 more weeks. At the last visit all subjects get memory and brain tests again.

Further study details as provided by University of California, Los Angeles:

Primary Outcome Measures:

Change in rate of reaction time as measured by neuropsychological testing [ Time Frame: 10 weeks of study drug exposure ] [ Designated as safety issue: No ]

The Conner's CPT-II at screening, and at weeks 1, 5, and 14.

Secondary Outcome Measures:

Number of Subjects with Adverse Events as Measures of Safety and Tolerability of Concerta in HIV infected adults [ Time Frame: 10 weeks of drug exposure ] [ Designated as safety issue: Yes ]

The number of subjects who develop adverse events while on study medication vs placebo will be used to measure the safety and tolerability of ConcertaTM at 36 mg a day in this population of adult subjects with HIV over both a two week and eight week treatment period. These measures are EKG changes, electrolyte, creatinine, liver function tests, blood pressure, quality of life and sleep quality scales.

For females of reproductive potential (women who have not been post-menopausal for at least 24 consecutive months, i.e., who have had menses within 24 months prior to study entry), or women who have not undergone surgical sterilization, specifically hysterectomy or bilateral oophorectomy or tubal ligation) will require a negative serum or urine pregnancy test within 48 hours prior to entry.

All subjects must agree not to participate in the conception process (e.g., active attempt to become pregnant or to impregnate, sperm donation, in vitro fertilization), and if participating in sexual activity that could lead to pregnancy, the subject/partner must use at least two reliable methods of contraception, (condoms, without a spermicidal agent; a diaphragm or cervical cap without spermicide; an IUD; or hormone-based contraceptive), for 2 weeks before study treatment, while receiving study treatment, and for 6 weeks after receiving study treatment.

Use of interferon or ribavirin during study and for 1 month prior to screening.

History of bipolar disorder, Alzheimer's dementia, ALS, Parkinson's disease or other medical dementias other than HIV-related.

History of schizophrenia, mania or other serious mental illness.

History of methylphenidate allergy.

Other serious concurrent medical illness other than HIV.

History of radiation therapy to the brain or brain injury.

History of crystal methamphetamine, cocaine, LSD use or other recreational substance use other than marijuana within the 12 months prior to screening and for the duration of the study.

Plan to use marijuana or marinol during the entire study duration and one month prior to screening visit.

Plan to drink 7 or more alcoholic drinks per week during the 4 weeks prior to screen visit and for the duration of the study.

History of alcohol dependence, alcohol abuse, cocaine addiction, crystal methamphetamine addiction or other recreational drug addiction or treatment for addiction or dependence within 5 years of screening visit.

If subject is using prescription narcotics, should be on a stable dose for at least 1 month prior to screening and throughout the study.

Previous use of Concerta™, Ritalin™, atomexitine or Adderall™ or other psychostimulants (e.g. modafinil, armodafinil) for 3 months prior to screening visit and for duration of the study.

History of tic disorders in the past 3 months or any history of Tourette's syndrome.

History of short gut syndrome, Meckel's diverticulum, or cystic fibrosis.

Family history of sudden cardiac death in a young relative.

History of fainting with exercise.

History of attention deficit disorder will be excluded, defined as a score greater than 6 on the Childhood ADHD Symptoms Scale.

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Contacts and Locations

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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01599975